[UPDATED 01/12/2012] FDA is updating healthcare professionals and the public about preliminary findings from ongoing investigations following the voluntary recall of CardioGen-82 by the manufacturer. FDA continues to work with the manufacturer and other federal agencies to better characterize the problems that led to excessive radiation exposure to patients at certain clinical sites, and is working with the manufacturer to revise the CardioGen-82 labeling to better describe how to use the generator.

ISSUE: FDA notified the public and the medical imaging community about the potential for inadvertent, increased radiation exposure in patients who underwent or will be undergoing cardiac positron emission tomography (PET) scans with rubidium (Rb)-82 chloride injection from CardioGen-82 manufactured by Bracco Diagnostics, Inc.

BACKGROUND: A CardioGen-82 PET scan is one of a variety of nuclear medicine scans and uses the radioactive drug Rb-82 chloride injection to evaluate the heart. FDA has received reports of two patients who received more radiation than expected from CardioGen-82. The excess radiation was due to strontium isotopes which may have been inadvertently injected into the patients due to a “strontium breakthrough” problem with CardioGen-82.

RECOMMENDATION: At this time, FDA believes that the risk of harm from this exposure is minimal, although any unnecessary exposure to radiation is undesirable. The estimated amount of excess radiation the two patients received is similar to that other patients may receive with cumulative exposure to certain other types of heart scans. It would take much more radiation to cause any severe adverse health effects in patients.

Healthcare professionals should closely follow the required testing and quality control procedures essential to help detect strontium breakthrough from CardioGen-82. Other types of heart scans provide information very similar to CardioGen-82 and professionals are encouraged to consider these alternatives while FDA completes its investigation of the reported cases of excess radiation exposure.

Patients who have recently had heart scans should talk to their healthcare professional if they have any questions. Patients who are planning to undergo a heart scan should talk to the healthcare professional if they are unsure of the type of planned heart scan and the radiation risks associated with the scan.

FDA is actively investigating the root cause of this failure with CardioGen-82 and will promptly notify the public with updates.